FDA Adverse Event
Malfunction
Summary report: N
FLEXTEND
MDR report key: 3212643
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-10060
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- May 17, 2013
- Report Date
- May 17, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENT WAS NOTED ON THIS PATIENT¿S RIGHT VENTRICULAR (RV) LEAD. NOISE AND OVERSENSING WERE ALSO NOTED AND THE PHYSICIAN BELIEVES THERE MIGHT BE A LEAD FRACTURE. DUE TO THE PATIENT¿S CURRENT METAL AND PHYSICAL HEALTH, THE LEADS WILL REMAIN IN SERVICE FOR NOW AND THE PLAN IS TO MONITOR THE PATIENT FOR THE TIME BEING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314206 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4088 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | 1290| 4087| 4088 |